IHS Global Insight Perspective | |
Significance | The United Kingdom's National Institute for Health and Clinical Excellence has said that Velcade and Thalomid are cost-effective treatments for first-line multiple myeloma, but Xolair is not considered cost effective for the treatment of severe persistent allergic asthma in children between the ages of 6 and 11. |
Implications | Despite the fact that both Velcade and Thalomid have been given the thumbs up, Thalomid is considered to be the more cost-effective drug, and NICE therefore recommends that Velcade is used in cases where Thalomid is not appropriate. For Xolair, its high cost in this patients group means the chance of securing NICE's recommendation appears to be slim, despite the drug's apparent benefits. |
Outlook | The guidance on all three drugs is only preliminary. It is therefore possible that Janssen-Cilag (U.S.) may seek to submit additional analysis on Velcade to broaden its use as a first-line treatment. This may also be the case for Novartis (Switzerland) in order to secure a recommendation for Xolair. |
Preliminary Guidance on Velcade and Thalomid
According to the appraisal consultation document, Velcade (bortezomib; Janssen-Cilag, U.S.) and Thalomid (thalidomide; Celgene, U.S.), both in combination with an alkylating agent and a corticosteroid, are considered to be cost effective in the evaluated indication. However, some restrictions apply: both drugs are only recommended in patients for whom high-dose chemotherapy with stem-cell transplantation is not appropriate. In addition, Velcade is only recommended for patients who are also intolerant to Thalomid, or those for whom Thalomid is contraindicated.
Both drugs were evaluated outside their licensed indications, and the National Institute for Health and Clinical Excellence (NICE) looked at different treatment regimens:
- Thalidomide, cyclophosphamide, and attenuated dexamethasone (CTDa).
- Bortezomib, melphalan, and prednisolone/prednisone (VMP).
- Thalidomide, melphalan, and prednisolone/prednisone (MPT).
The manufacturer's submission for the cost effectiveness of Velcade was based on a decision-analytic cost-utility model comparing VMP, CTDa, and MPT with melphalan and prednisolone/prednisone (MP). The base-case incremental cost-effectiveness ratios (ICERs) per quality-adjusted life year (QALY) gained for the respective treatment combinations were £10,498 (US$15,416), £10,905, and £8,912.
Celgene (U.S.) used a Markov model in its cost-effectiveness analysis of Thalomid. The base-case ICERs per QALY gained were £23,381 for MPT in comparison with MP, and £303,845 for VMP in comparison with MPT.
In separate analysis, NICE's assessment group produced base-case ICERs per QALY of £29,837, £33,216, and £9,174 for VMP, CTDa, and MPT respectively, in comparison with MP. According to NICE, the difference in the cost-effectiveness estimates between the manufacturer's analysis and that of the assessment group was due to differences in the assumption made in the two models. NICE concluded that Velcade is less cost effective than Thalomid. However, it is still cost effective as a first-line treatment of multiple myeloma, and therefore can be used in patients who have contraindications to Thalomid. For Thalomid, NICE said that the manufacturer's base-case cost-effectiveness estimates were robust, and the drug is therefore a cost-effective treatment for first-line multiple myeloma. The appraisal consultation document is available here.
Preliminary Guidance on Xolair
In a separate appraisal consultation document, Xolair (omalizumab; Novartis, Switzerland) was evaluated for the treatment of severe persistent allergic asthma in children between the ages of 6 and 11. According to the manufacturer's economic analysis, the base-case ICER per QALY gained was £91,188 for the European Union population group, and £65,991 for the high-risk hospitalisation subgroup in comparison with the standard of care. NICE agreed that these were the most plausible cost-effectiveness estimates. Due to these high ICERs, Xolair in this patient group is not considered to be a cost effective use of National Health Service (NHS) resources, and therefore NICE recommends that it should not be made available to patients. The appraisal consultation document is available here.
Outlook and Implications
This preliminary positive guidance will be a boost for Thalomid, which was approved for the treatment of multiple myeloma in 2007. Now that NICE has concluded that the drug is cost effective in patients who cannot be treated with high-dose chemotherapy and stem-cell transplantation, it is likely that the uptake of the drug in this patient population will increase. For Velcade, the conclusions of this preliminary recommendation are mixed. A comparison of both drugs has shown that Thalomid is more cost effective, and therefore the use of Velcade in the treatment of multiple myeloma will be a great deal more restricted. However, given Janssen-Cilag's previous experience trying to secure a reimbursement recommendation from NICE for Velcade as a second-line treatment, it is commendable that it has been able to secure a recommendation this time around without having to resort to a patient-access scheme (see United Kingdom: 4 June 2007: NICE U-Turns on Velcade As Manufacturer Offers Refund if Bone Marrow Cancer Drug Fails). It is therefore possible that the company will seek to produce further cost-effectiveness data to expand the use of the drug on the NHS.
Following NICE's negative verdict on Xolair, Novartis has issued a statement expressing its disappointment at the decision, and insisting that the clinical evidence for the drug shows that it reduces asthma attacks by one-third after 24 weeks of treatment, and by half after one year of treatment. Novartis has not commented on the cost-effectiveness data for the drug, which remains one of the main determinants in securing a recommendation from NICE. Given that this is only a preliminary decision, it is possible that Novartis could look at available options to demonstrate improved cost effectiveness. Xolair is already reimbursed in the United Kingdom, for patients aged 12 and older, suffering from severe and persistent allergic asthma (see United Kingdom: 27 November 2007: NICE Approves Reimbursement of Novartis' Xolair for Allergic Asthma).